Clinical Operations
Clinical Project ManagementStudy Monitoring and Site ManagementTrial Master File and Document ManagementQuality and Vendor Management SystemsStudy DocumentsRegulatory Affairs
Regulatory StrategyRegulatory WritingAgency Communications and SubmissionsDocument Editorial, QC and SubmissionQC, Review and RedactionLegal RepresentationPharmacovigilanceILAP SubmissionsMedical Communications
Publication PlanningStrategic CommunicationsScientific CommunicationsMedical EducationMedical IllustrationGrant Applications and Project Partnership
Clinical responsibilities included:
Managerial Responsibilities
"Niche was instrumental in constructing realistic costing models for the project. On reviewing our submission, the MRC noted that having a CRO involved inspired confidence that this many-faceted project, involving so many contributors, would be successful."




Niche has been successfully managing the executive function of the RASP-UK consortium since the grant was awarded in 2014. The consortium consists of 13 clinical-academic centres, eight industry contributors and seven ancillary partners (organisations like Asthma UK) and is governed by an Executive Team. In serving RASP-UK, Niche provides regulatory, operational and oversight services in delivery of four separate work strands that currently incorporate seven clinical trials. Niche also works closely with patient groups through the RASP-UK patient input platform.
When the original CRO walked out mid-trial, Niche stepped in to rescue and deliver this EU-funded, 74-site European.
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